BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT ACETABULAR SYSTEM

    MDR report key: 1916361 · Received November 29, 2010

    Report

    Report Number
    9616680-2010-00768
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICES ARE NOT AVAILABLE DUE TO THE ONGOING LITIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PATIENT UNDERWENT A TRIDENT HIP REPLACEMENT SURGERY". IT WAS FURTHER REPORTED THAT, "THE PATIENT ALLEGES DAMAGES FOR AN UNKNOWN INJURY RELATING TO THE TRIDENT SYSTEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT ACETABULAR SYSTEM IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention